UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035328
Receipt number R000040201
Scientific Title A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis
Date of disclosure of the study information 2018/12/20
Last modified on 2019/12/27 16:15:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis

Acronym

A multicenter retrospective study on descending necrotizing mediastinitis

Scientific Title

A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis

Scientific Title:Acronym

A multicenter retrospective study on descending necrotizing mediastinitis

Region

Japan


Condition

Condition

Descending necrotizing mediastinitis

Classification by specialty

Surgery in general Gastrointestinal surgery Chest surgery
Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Survey on the clinical practice of descending necrotizing mediastinitis in Japan

Basic objectives2

Others

Basic objectives -Others

evaluation of the postoperative outcomes

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

postoperative 30-day mortality

Key secondary outcomes

postoperative 90-day mortality, 1-year survival rate, duration of mechanichal ventilation, postoperative hospital stay.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Descending necrotizing mediastinitis treated in JBES/JACS hospitals from January 2012 to December 2016.

Key exclusion criteria

Patients who refused to participate in the study.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kenji, Yoshimasa
Middle name
Last name Sugio, Maniwa

Organization

Oita University
Kobe University

Division name

Department of Thoracic and Breast Surgery

Zip code

879-5593

Address

1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan

TEL

097-586-5854

Email

geka2@oita-u.ac.jp


Public contact

Name of contact person

1st name Tatsuro
Middle name
Last name Okamoto

Organization

Oita University

Division name

Department of Thoracic and Breast Surgery

Zip code

879-5593

Address

1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan

TEL

097-586-5854

Homepage URL


Email

jbes1703-jacs1806@oita-u.ac.jp


Sponsor or person

Institute

Oita University, Department of Thoracic and Breast Surgery

Institute

Department

Personal name



Funding Source

Organization

The Japan Broncho-eshophagological Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kobe University, Department of General Thoracic Surgery

Name of secondary funder(s)

The Japanese Association for Chest Surgery


IRB Contact (For public release)

Organization

The institutional review boards of Oita University

Address

1-1, Idaigaoka, Hasama-cho, Yufu-shi, Oita 879-5593, Japan

Tel

097-586-5125

Email

rinrikenkyu@oita-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 01 Month 29 Day

Date of IRB

2018 Year 04 Month 16 Day

Anticipated trial start date

2019 Year 03 Month 31 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

Retrospective observational study using a questionnair form


Management information

Registered date

2018 Year 12 Month 20 Day

Last modified on

2019 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name